Date Initiated by Firm | May 29, 2019 |
Create Date | July 30, 2019 |
Recall Status1 |
Terminated 3 on May 12, 2022 |
Recall Number | Z-2135-2019 |
Recall Event ID |
82990 |
510(K)Number | K051650 |
Product Classification |
Immunoassay method, troponin subunit - Product Code MMI
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Product | Stratus CS Acute Care cTNI TestPak, SMN 10445071
Product Usage:
In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). |
Code Information |
Lot # 238330002 forward Expiration Dates - May 25, 2019 - November 2, 2019 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics Inc 2 Edgewater Dr Norwood MA 02062-4637
|
For Additional Information Contact | 781-269-3000 |
Manufacturer Reason for Recall | Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On May 29, 2019, Siemens issued Urgent Medical Device Correction notices to U.S.A. customers via FedEx courier service and Urgent Field Safety Notices to international customers via email.
Actions to be Taken by the Customer:
1. Do not use TestPaks within 2 mos of expiration.
2. Repeat samples with cTNL results above 0.07 ng/mL or your institution's established 99th percentile value.
3. Complete and return the Field Correction Effectiveness Check form
4. Retain a copy of the letter with your laboratory records and forward a copy of the notice to anyone to whom you may have distributed the product.
Siemens is working to resolve this issue and will contact customers when additional information is available. Siemens will reimburse users for repeat tests and discarded cTNL TestPaks within 2 months of the printed expiration date associated with this field corrective action. |
Quantity in Commerce | 2312 |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MMI
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